RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide works in treating patients with advanced prostate cancer that did not respond to hormone therapy.

250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.

Drug: etoposide

50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).

Other: laboratory biomarker analysis

The blood samples will be obtained in EDTA tubes, spun down, and the serum removed and stored at 80 degrees C in small aliquots for later use. When we have sufficient samples to use a kit, they will be thawed and sampled for the various biomarkers using ELISA kits from R&D Technology (Seattle). The antiEGFR antibodies will also be determined by using ELISA, but with kits prepared within our institution.

Detailed Description:

OBJECTIVES:

Primary

Determine the activity of gefitinib and etoposide, in terms of overall response rate, in patients with hormone-refractory advanced prostate cancer previously treated with docetaxel-based therapy.

Secondary

Determine the toxicity of this regimen in these patients.

Determine whether related biomarkers can help predict response in patients treated with this regimen.

OUTLINE: This is a nonrandomized study.

Patients receive oral gefitinib once daily on days 1-28 and oral etoposide once daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Blood samples are analyzed by enzyme-linked immunosorbent assays for biomarkers (e.g., VEGF, basic fibroblast growth factor, and anti-EGFR antibody titers) in order to determine whether one or more of these biomarkers can predict response.

After completion of study therapy, patients are followed periodically.

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate

Progressive disease after a prior docetaxel-based regimen OR failed a prior docetaxel-based regimen

Hormone-refractory disease, meeting 1 of the following criteria:

Radiologically measurable disease

Prostate-specific antigen (PSA) progression* while on hormonal therapy (including withdrawal from a direct antagonist) NOTE: *If the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA is required to document progression

Must have underwent prior surgical castration OR currently be on a luteinizing hormone-releasing hormone agonist

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483561

Locations

United States, Nebraska

UNMC Eppley Cancer Center at the University of Nebraska Medical Center